Ovarian Cancer Clinical Trial

Alpelisib Plus Olaparib in Platinum-resistant/Refractory, High-grade Serous Ovarian Cancer, With no Germline BRCA Mutation Detected

Summary

The objective of this study is to assess the efficacy and safety of the combination of alpelisib and olaparib compared with single agent cytotoxic chemotherapy in patients with platinum resistant or refractory high-grade serous ovarian cancer, with no germline BRCA mutation detected.

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Full Description

This study will include adult women with platinum resistant or refractory high-grade serous ovarian cancer, with no germline BRCA mutation detected. Participants will be randomized in a 1:1 ratio to either alpelisib plus olaparib or single agent cytotoxic chemotherapy (paclitaxel or PLD) in this open-label, active controlled study.

Participants will continue to receive study treatment until disease progression, unacceptable toxicity that precludes further treatment, or until discontinuation of study treatment due to any other reason. After treatment discontinuation, all participants will enter in the post-treatment follow-up period, which consists of a safety follow-up visit and a 9-week post-progression visit. Once they complete the post-treatment follow-up, participants will then enter the survival follow-up period.

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Eligibility Criteria

Inclusion Criteria:

Participant has histologically confirmed diagnosis of high-grade serous or high-grade endometrioid ovarian cancer, fallopian tube cancer, or primary peritoneal cancer
Measurable disease, i.e., at least one measurable lesion per RECIST 1.1 criteria (a lesion at a previously irradiated site may only be counted as a target lesion if there is clear sign of progression since the irradiation)
If no measurable disease is present, the disease should be assessable by Gynecologic Cancer Intergroup criteria (GCIC) for CA-125
Participant has no germline BRCA1/2 mutation as determined by an FDA approved assay.
Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Participant has platinum-resistant (progression within one to six months after completing platinum-based therapy) or platinum refractory disease (progression during treatment or within 4 weeks after the last dose), where platinum-based therapy is not an option, according to the GCIG 5th Ovarian Cancer Consensus Conference definitions. The platinum-based chemotherapy regimen does not necessarily need to be the last regimen the participant received prior to study entry.
Participant must have received at least one but no more than three prior systemic treatment regimens and for whom single-agent chemotherapy is appropriate as the next line of treatment.
Participant has adequate bone marrow and organ function

Exclusion Criteria:

Participant has received prior treatment with any PI3K, mTOR or AKT inhibitor.
Participant is concurrently using other anti-cancer therapy
Participant is in a state of small or large bowel obstruction or has other impairment of gastrointestinal (GI) function or GI disease
Participant has had surgery within 14 days prior to starting study drug or has not recovered from major side effects
Participant has not recovered from all toxicities 5 related to prior anticancer therapies to baseline or NCI CTCAE Version 4.03 Grade ≤1. Exception to this criterion: participants with any grade of alopecia are allowed to enter the study.
Participants with liver impairment and Child Pugh score B or C
Participant has received radiotherapy ≤ 4 weeks or limited field radiation for palliation ≤2 weeks prior to randomization, and who has not recovered to baseline, grade 1 or better from related side effects of such therapy (with the exception of alopecia).
Participant has a known hypersensitivity to any of the study drugs or excipients

Other inclusion/exclusion criteria may apply

Study is for people with:

Ovarian Cancer

Phase:

Phase 3

Estimated Enrollment:

358

Study ID:

NCT04729387

Recruitment Status:

Active, not recruiting

Sponsor:

Novartis Pharmaceuticals

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There are 93 Locations for this study

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Arizona Oncology Associates SC
Phoenix Arizona, 85016, United States
HonorHealth
Phoenix Arizona, 85016, United States
Florida Cancer Specialists
Fort Myers Florida, 33901, United States
Florida Cancer Specialists
West Palm Beach Florida, 33401, United States
Maryland Oncology Hematology P A .
Silver Spring Maryland, 20904, United States
Massachusetts General Hospital Massachusetts General Hospital
Boston Massachusetts, 02114, United States
Dana Farber Cancer Institute .
Boston Massachusetts, 02115, United States
Memorial Sloan Kettering Cancer Ctr .
New York New York, 10065, United States
Oncology Hematology Care Inc
Cincinnati Ohio, 45242, United States
University Of Cincinnati Dept of Oncology
Cincinnati Ohio, 45267, United States
Avera Cancer Institute
Sioux Falls South Dakota, 57106, United States
Sarah Cannon Research Institute
Nashville Tennessee, 37203, United States
Texas Oncology P A Texas Oncology - South Austin
Bedford Texas, 76022, United States
Texas Oncology Charles A. Sammons Cancer Ctr
Dallas Texas, 75246, United States
Texas Oncology P A .
San Antonio Texas, 78217, United States
Texas Oncology Northeast Texas
Tyler Texas, 75702, United States
Novartis Investigative Site
Caba Buenos Aires, C1056, Argentina
Novartis Investigative Site
Caba Buenos Aires, C1125, Argentina
Novartis Investigative Site
Ciudad Autonoma de Bs As Buenos Aires, C1015, Argentina
Novartis Investigative Site
Buenos Aires , C1012, Argentina
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Randwick New South Wales, 2031, Australia
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Bedford Park South Australia, 5041, Australia
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Shepparton Victoria, 3630, Australia
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Innsbruck Tyrol, 6020, Austria
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Graz , 8036, Austria
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Bruxelles , 1000, Belgium
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Leuven , 3000, Belgium
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Namur , 5000, Belgium
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Belo Horizonte Minas Gerais, 30130, Brazil
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Sao Paulo SP, 04014, Brazil
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Calgary Alberta, T2N 4, Canada
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Vancouver British Columbia, V5Z 4, Canada
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London Ontario, N6A 5, Canada
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Toronto Ontario, M4N 3, Canada
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Chengdu Sichuan, 61004, China
Novartis Investigative Site
Beijing , 10003, China
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Jinan , 25001, China
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Shanghai , 20003, China
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Tianjin , 30048, China
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Novy Jicin Czech Republic, 74101, Czechia
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Ostrava Poruba , 708 5, Czechia
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Praha 2 , 128 5, Czechia
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Herlev , 2730, Denmark
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Odense C , DK 50, Denmark
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Kuopio , FIN-7, Finland
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Tampere , FIN-3, Finland
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Turku , FIN 2, Finland
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Besancon , 25030, France
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Lyon , 69373, France
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Paris , 75012, France
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Pierre Benite , 69495, France
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Villejuif , 94800, France
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Mannheim Baden Wuerttemberg, 68305, Germany
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Berlin , 13353, Germany
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Dresden , 01307, Germany
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Essen , 45136, Germany
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Bologna BO, 40138, Italy
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Firenze FI, 50134, Italy
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Milano MI, 20133, Italy
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Milano MI, 20141, Italy
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Roma RM, 8-001, Italy
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Vicenza VI, 36100, Italy
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Napoli , 80131, Italy
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Seoul , 03080, Korea, Republic of
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Seoul , 03722, Korea, Republic of
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Kota Kinabalu Sabah, 88996, Malaysia
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Kuching Sarawak, 93586, Malaysia
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Kuala Lumpur Wilayah Persekutuan, 50586, Malaysia
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Kuala Lumpur , 59100, Malaysia
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Monterrey Nuevo Leon, 64460, Mexico
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Ciudad de Mexico , 04700, Mexico
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Eindhoven , 5623 , Netherlands
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Loures , 26745, Portugal
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Porto , 4200-, Portugal
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Arkhangelsk , 16304, Russian Federation
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Singapore , 11922, Singapore
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Singapore , 16858, Singapore
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Bratislava , 83310, Slovakia
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Cordoba Andalucia, 14004, Spain
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Barcelona Catalunya, 08035, Spain
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Barcelona Catalunya, 08036, Spain
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Valencia Comunidad Valenciana, 46010, Spain
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Pamplona Navarra, 31008, Spain
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Madrid , 28034, Spain
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Taichung , 40705, Taiwan
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Taipei , 10002, Taiwan
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Taipei , 11217, Taiwan
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Adana , 01160, Turkey
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Ankara , 06100, Turkey
Novartis Investigative Site
Ankara , 06520, Turkey
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Izmir , 35575, Turkey
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Glasgow , G12 0, United Kingdom
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London , SE1 9, United Kingdom
Novartis Investigative Site
Manchester , M20 4, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Phase 3

Estimated Enrollment:

358

Study ID:

NCT04729387

Recruitment Status:

Active, not recruiting

Sponsor:


Novartis Pharmaceuticals

How clear is this clinincal trial information?

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